Comparison of Hyaluronic Acid and Platelet-rich Plasma Injections

January 13, 2020 updated by: Bezmialem Vakif University

Comparison of Hyaluronic Acid and Platelet-rich Plasma Injection on Pain, Physical Function and Femoral Cartilage Thickness in Patients With Osteoarthritis

This study aims to compare the effects of hyaluronic acid injection and platelet rich plasma injection in terms of pain, physical function and femoral cartilage thickness in short term treatment in patients with knee osteoarthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Platelet-rich plasma and hyaluronic acid injections are both popular treatments and commonly used for treatment of knee osteoarthritis. Even though there are many studies investigating the effectiveness of these treatments, the results are mostly qualitative. Also there are a few studies comparing these two treatment modalities. In this study the investigators aim to compare these modalities both for self-reported data (pain, physical function) and objective measurement data (femoral cartilage thickness via ultrasonography). Patients with unilateral osteoarthritis/unilateral complaint will be included in the study. Unaffected side will be controls for each group.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34093
        • Bezmialem Vakif University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is able to consent
  • Subject meets Osteoarthritis Research Society International (OARSI) criteria for knee osteoarthritis
  • Subject has radiographic Kellgren-Lawrence grade 2-3 osteoarthritis
  • Unilateral osteoarthritis/complaint

Exclusion Criteria:

  • Past or actual knee infection
  • History of surgery, fracture on knee
  • Collagen tissue disease
  • Systemic inflammatory disease (rheumatoid arthritis, spondyloarthritis etc.)
  • Systemic diseases (diabetes, hematologic diseases, endocrinopathies, renal failure, liver failure)
  • Knee injection in past 6 months
  • Immunodeficiency
  • Pregnant/breastfeeding
  • Malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Hyaluronic acid injection
Hyaluronic acid 48 mg 2.0% in 2 ml solution, once initially.
Biological: Hyaluronic acid injection
Hyaluronic acid 48 mg 2.0% in 2.4 ml solution
Other Names:
  • Reviscon Mono
ACTIVE_COMPARATOR: Platelet-rich plasma injection
Platelet-rich plasma 5 ml, once initially
Biological: Platelet-rich plasma injection
Platelet-rich plasma injection 5ml
NO_INTERVENTION: Unaffected side Hyaluronic acid
Unaffected sides of the patients will be controls for hyaluronic acid group, no intervention.
NO_INTERVENTION: Unaffected side Platelet-rich plasma
Unaffected sides of the patients will be controls for Platelet-rich plasma group, no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of numeric rating scale (rest, movement)
Time Frame: 0, 1st, 6th, months
Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome.
0, 1st, 6th, months
Change of Western Ontario and McMaster Universities Osteoarthritis Index score(WOMAC)
Time Frame: 0, 1st, 6th months
Self reported questionnaire investigating 24 daily living activities. Each item is scored 0-5 (0:none 5:worst). Yielding a total between 0-100. Higher scores represent a worse outcome.
0, 1st, 6th months
Change of femoral cartilage thickness via ultrasonography.
Time Frame: 0, 1st, 6th months
Transverse plane femoral cartilage thickness from three landmarks (from articular cartilage pothole,from midpoint of medial border and pothole of cartilage, from midpoint of lateral border and pothole of cartilage). Measured in millimeters. The sum of three points indicate a total thickness. A higher measurement indicates a thicker cartilage representing a better outcome.
0, 1st, 6th months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Study Director: Teoman Aydın, Prof, MD, Bezmialem Vakif University
  • Principal Investigator: Ozan Volkan Yurdakul, MD, Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

January 13, 2020

Study Completion (ACTUAL)

January 13, 2020

Study Registration Dates

First Submitted

November 23, 2018

First Submitted That Met QC Criteria

November 30, 2018

First Posted (ACTUAL)

December 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71306642-050.01.04-

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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